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Twist Precision Prep and Enrichment Dx Kit, 96 samples (B) - Box 1

by Twist Bioscience Corporation United States EUDAMED

Ref 107623

EMDN W010699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081011955TPPEDxKLE Basic UDI-DIDate18 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Twist Precision Prep and Enrichment Dx Kit
Model / Reference
107623
Primary DI / UDI-DI
00810119550118
Basic UDI-DI
081011955TPPEDxKLE
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000039181
Authorised representative
QAdvis EAR AB SE-AR-000001599

Other devices from Twist Bioscience Corporation

See all devices from Twist Bioscience Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
  • New Device
Other properties (7)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 929da1c2-d0ac-4806-91c9-0ed0a10802bd 61 fields · synced 22 Oct 2026